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Micro-Dose, Macro-Impact: Leveraging Psychedelics in Frontline Healthcare Workers During the COVID-19 Pandemic

Primary Purpose

Acute Stress Disorder

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sublingual Micro-Dose Ketamine
Sponsored by
Limbic Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Stress Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Greater than 18 years of age
  2. Demonstrate capacity to consent to the study
  3. A Frontline Health Care Worker-defined as any EMS personnel (firefighter, EMT, flight nurse, etc.), or any hospital-based worker (particularly in the ED, ICU, or OR) such as an RN, MD/DO, or non-clinical support staff (EVS, etc.)
  4. Experiencing acute stress disorder as determined by clinically validated screening tools -

Exclusion Criteria:

  1. Currently on prescription medications for psychiatric issues
  2. Currently pregnant or breastfeeding or actively trying to get pregnant
  3. History of seizure disorder, liver disease, or psychosis/mania
  4. Uncontrolled Hypertension
  5. Physician discretion: any condition deemed inappropriate that will increase the risk -

Sites / Locations

  • Limbic Medical

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sublingual Micro-Dose Ketamine

Arm Description

Ketamine micro-dose 37.5mg compounded sublingual daily administration

Outcomes

Primary Outcome Measures

Patient self-reported outcome measure
Perceived Stress Scale
Patient self-reported outcome measure
15-Dimensional Health-Related Quality of Life Questionnaire 15-Dimensional Health-Related Quality of Life Questionnaire
Patient self-reported outcome measure
PCL-5 (PTSD checklist for DSM-5)
Patient self-reported outcome measure
Physical Health- NIH PROMIS Global
Patient self-reported outcome measure
Mental Health- NIH PROMIS Global
Patient self-reported outcome measure
Health Perception and Social Roles
Patient self-reported outcome measure
Doctor's Note
Patient self-reported outcome measure
NIH PROMIS CAT- Depression
Patient self-reported outcome measure
NIH PROMIS CAT Neuro-QOL-Anxiety

Secondary Outcome Measures

Full Information

First Posted
February 22, 2021
Last Updated
February 23, 2021
Sponsor
Limbic Medical
Collaborators
Enovex Pharmacy
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1. Study Identification

Unique Protocol Identification Number
NCT04769297
Brief Title
Micro-Dose, Macro-Impact: Leveraging Psychedelics in Frontline Healthcare Workers During the COVID-19 Pandemic
Official Title
Micro-Dose, Macro-Impact: Leveraging Psychedelics in Frontline Healthcare Workers During the COVID-19 Pandemic
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 15, 2020 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Limbic Medical
Collaborators
Enovex Pharmacy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
A retrospective chart review of an open-label trial of low-dose ketamine administered to front-line Healthcare workers who were identified as experiencing acute stress disorder due to the COVID-19 Pandemic.
Detailed Description
An investigation of a novel, off-label use of an FDA approved drug (ketamine) in a low(micro) dose sublingual formulation of ketamine provided to front-line healthcare workers who were identified as suffering from acute stress disorder. The study was conducted completely virtually via real-time telemedicine for physician visits and via asynchronous interaction for outcomes data collection. Patients self-referred to the study via email outreach, and diagnosis was confirmed by medically validated screening assessments and study physician confirmation. Once treatment was initiated, patients were seen via live telemedicine every 40 days while treatment response/outcomes data was collected weekly and monthly. Patients were treated up to 120 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Retrospective, Open-label chart review
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sublingual Micro-Dose Ketamine
Arm Type
Experimental
Arm Description
Ketamine micro-dose 37.5mg compounded sublingual daily administration
Intervention Type
Drug
Intervention Name(s)
Sublingual Micro-Dose Ketamine
Intervention Description
daily micro-dosing of frontline healthcare workers suffering from acute stress disorder due to the COVID-19 pandemic
Primary Outcome Measure Information:
Title
Patient self-reported outcome measure
Description
Perceived Stress Scale
Time Frame
up to 120 days
Title
Patient self-reported outcome measure
Description
15-Dimensional Health-Related Quality of Life Questionnaire 15-Dimensional Health-Related Quality of Life Questionnaire
Time Frame
up to 120 days
Title
Patient self-reported outcome measure
Description
PCL-5 (PTSD checklist for DSM-5)
Time Frame
up to 120 days
Title
Patient self-reported outcome measure
Description
Physical Health- NIH PROMIS Global
Time Frame
up to 120 days
Title
Patient self-reported outcome measure
Description
Mental Health- NIH PROMIS Global
Time Frame
up to 120 days
Title
Patient self-reported outcome measure
Description
Health Perception and Social Roles
Time Frame
up to 120 days
Title
Patient self-reported outcome measure
Description
Doctor's Note
Time Frame
up to 120 days
Title
Patient self-reported outcome measure
Description
NIH PROMIS CAT- Depression
Time Frame
up to 120 days
Title
Patient self-reported outcome measure
Description
NIH PROMIS CAT Neuro-QOL-Anxiety
Time Frame
up to 120 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Greater than 18 years of age Demonstrate capacity to consent to the study A Frontline Health Care Worker-defined as any EMS personnel (firefighter, EMT, flight nurse, etc.), or any hospital-based worker (particularly in the ED, ICU, or OR) such as an RN, MD/DO, or non-clinical support staff (EVS, etc.) Experiencing acute stress disorder as determined by clinically validated screening tools - Exclusion Criteria: Currently on prescription medications for psychiatric issues Currently pregnant or breastfeeding or actively trying to get pregnant History of seizure disorder, liver disease, or psychosis/mania Uncontrolled Hypertension Physician discretion: any condition deemed inappropriate that will increase the risk -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre Atoian, MD
Organizational Affiliation
Limbic Medical
Official's Role
Principal Investigator
Facility Information:
Facility Name
Limbic Medical
City
Toluca Lake
State/Province
California
ZIP/Postal Code
91602
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Micro-Dose, Macro-Impact: Leveraging Psychedelics in Frontline Healthcare Workers During the COVID-19 Pandemic

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